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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 46
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MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 46 Back to Search Results
Catalog Number 01.26.46MB
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 11/21/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(4) 2017.Lot: (b)(4) items manufactured and released on 21 sept 2016.Expiration date: 2021-08-290 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient came in complaining of pain.The surgeon determined the cup was loose.The cause of the loosening is unknown.The patient did not express any trauma.The surgery was completed successfully.
 
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Brand Name
VERSAFITCUP ACETABULAR SHELL Ø 46
Common Device Name
ACETABULAR SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ  6874
MDR Report Key7137287
Report Number3005180920-2017-00763
Device Sequence Number1328037
Product Code MEH
UDI-Device Identifier07630030808012
UDI-Public07630030808012
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K083116
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date08/29/2021
Device Catalogue Number01.26.46MB
Device Lot Number163137
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/21/2017
Initial Report FDA Received Date12/21/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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